Phase
Condition
Idiopathic Pulmonary Fibrosis
Cystic Fibrosis
Lung Injury
Treatment
BI 1839100
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
For Idiopathic Pulmonary Fibrosis (IPF) cohort:
Minimum age: 40 years
Diagnosis of IPF
Chronic cough (>8 weeks prior to Visit 1) attributed to IPF and refractory to treatment for known causes (Principal Investigator (PI) assessment)
Cough Severity visual analogue scale (VAS) ≥30 mm at Visit 1 and Visit 2B
Forced vital capacity (FVC) ≥45% of predicted normal at Visit 1
Diffusing capacity of the lungs for carbon monoxide (DLCO) >25% of predicted normal at Visit 1
Patients may be either:
On stable therapy with nintedanib or pirfenidone for ≥12 weeks prior to Visit 1 and are planning to stay on this background treatment for the whole trial duration. Combination of nintedanib plus pirfenidone will not be allowed
Not on therapy with nintedanib or pirfenidone for ≥12 weeks prior to Visit 1 (either antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start AF treatment during the trial. It is not permitted to delay nintedanib or pirfenidone therapy for the purpose of participating in this trial
Patients aged ≥40 years when signing the informed consent
For Progressive Pulmonary Fibrosis (PPF) cohort:
Minimum age: 18 years
Diagnosis of PPF
Chronic cough (>8 weeks prior to Visit 1) attributed to PPF, refractory to treatment for known causes (PI assessment)
Cough Severity VAS ≥30 mm at Visit 1 and Visit 2B
FVC ≥45% of predicted normal at Visit 1
DLCO ≥25% of predicted normal at Visit 1
If receiving immunomodulatory therapy for interstitial lung disease (ILD), allowed medications include tacrolimus, mycophenolate mofetil, or azathioprine (stable dose for 12 weeks prior to Visit 1)
Patients may be either:
On a stable therapy with nintedanib for ≥12 weeks prior to Visit 1 and are planning to stay on this background treatment for the whole trial duration
Not on a therapy with nintedanib for ≥12 weeks prior to Visit 1 (either AF-treatment naïve or previously discontinued) and do not plan to start or re-start AF treatment during the trial. It is not permitted to delay nintedanib or pirfenidone therapy for the purpose of participating in this trial
Patients aged >18 years when signing the informed consent Further inclusion criteria apply.
Exclusion criteria for IPF and PPF cohorts:
Acute exacerbation of IPF/PPF within 12 weeks prior to Visit 1
Forced expiratory volume in 1 second (Forced expiratory volume in 1 second (FEV1))/FVC <0.7 at Visit 1
Known reversible airflow obstruction/response to bronchodilators
In the opinion of the Investigator, other clinically significant pulmonary abnormalities, including primary bronchitic and bronchiectatic disorder
Upper or lower respiratory tract infection within 4 weeks prior to Visit 1
Ongoing chronic pulmonary infection (e.g. mycobacterial or fungal disease)
Current smokers (tobacco use within the 6 months prior to Visit 1)
Initiation or change in supplemental oxygen requirement during 4 weeks prior to Visit 1 Further exclusion criteria apply.
Study Design
Connect with a study center
Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
C.a.b.a, C1027AAP
ArgentinaSite Not Available
CEDIC - Centro de Investigacion Clinica
Caba, C1060ABN
ArgentinaSite Not Available
Centro de Investigación Clinica Belgrano
Caba, 1425
ArgentinaSite Not Available
Hospital Britanico de Buenos Aires
Caba, 1280AEB
ArgentinaSite Not Available
Consultorios Médicos del Buen Ayre
Capital Federal, 1425
ArgentinaSite Not Available
Canberra Hospital
Canberra, Australian Capital Territory 2605
AustraliaSite Not Available
Royal Prince Alfred Hospital
Camperdown, Sydney, New South Wales 2050
AustraliaSite Not Available
Macquarie University
Macquarie Park, New South Wales 2109
AustraliaSite Not Available
Launceston Respiratory & Sleep Centre
Launceston, Tasmania 7250
AustraliaActive - Recruiting
Lung Research Victoria
Footscray, Victoria 3011
AustraliaActive - Recruiting
Austin Hospital
Heidelberg, Victoria 3084
AustraliaSite Not Available
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaSite Not Available
Institute for Respiratory Health
Nedlands, Western Australia 6009
AustraliaSite Not Available
Medical University of Graz State Hospital - University Hospital Graz
Graz, 8036
AustriaSite Not Available
Krems University Hospital
Krems, 3500
AustriaSite Not Available
Hospital Elisabethinen Linz
Linz,
AustriaSite Not Available
Kepler Univ. Klinikum Linz
Linz, 4020
AustriaSite Not Available
Clinic Floridsdorf
Vienna, 1210
AustriaSite Not Available
Klinikum Wels - Grieskirchen GmbH
Wels, 4600
AustriaSite Not Available
Brussels - UNIV Saint-Luc
Bruxelles, 1200
BelgiumSite Not Available
UNIV UZ Gent
Gent, 9000
BelgiumSite Not Available
Centre Hospitalier Universitaire de Liège
Liège, 4000
BelgiumSite Not Available
Liège - HOSP CHR de la Citadelle
Liège, 4000
BelgiumSite Not Available
Serviços Medicos Respirar Sul Fluminense
Barra Mansa, 27323240
BrazilSite Not Available
Faculdade de Medicina de Botucatu - UNESP
Botucatu, 18618-687
BrazilSite Not Available
CLARE - Clinica de Pneumologia
Goiania, 74110-030
BrazilSite Not Available
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, 90035-074
BrazilSite Not Available
Netspiro Clinica Medica Ltda - Respsono
Sao Bernardo do Campo, 09750-420
BrazilSite Not Available
Hospital Alemao Oswaldo Cruz
Sao Paulo, 01327-001
BrazilSite Not Available
Hospital das Clinicas da FMUSP
São Paulo, 05403-000
BrazilSite Not Available
Gordon & Leslie Diamond Health Care Centre (UBC)
Vancouver, British Columbia V5Z 1M9
CanadaActive - Recruiting
St. Paul's Hospital (Vancouver)
Vancouver, British Columbia V6Z 1Y6
CanadaSite Not Available
St. Joseph's Healthcare Hamilton
Hamilton, Ontario L8N 4A6
CanadaActive - Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec H2X 3E4
CanadaActive - Recruiting
CIC Mauricie Inc.
Trois-Rivieres, Quebec G8T 7A1
CanadaSite Not Available
Beijing Chao-Yang Hospital
Beijing, 100020
ChinaSite Not Available
The Second Xiangya Hospital Of Central South University
Changsha, 410011
ChinaActive - Recruiting
People's Hospital of Sichuan Province
Chengdu, 610072
ChinaActive - Recruiting
West China Hospital
Chengdu, 610041
ChinaActive - Recruiting
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120
ChinaActive - Recruiting
Hangzhou First People's Hospital
Hangzhou, 310006
ChinaSite Not Available
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, 310016
ChinaSite Not Available
Zhejiang Hospital
Hangzhou, 310013
ChinaActive - Recruiting
Anhui Provincial Hospital
Hefei, 230001
ChinaActive - Recruiting
Nanjing Drum Tower Hospital
Nanjing, 210008
ChinaActive - Recruiting
Shanghai Chest Hospital
Shanghai, 200030
ChinaSite Not Available
Shanghai Pulmonary Hospital
Shanghai, 200433
ChinaActive - Recruiting
China Shenyang Chest Hospital
Shenyang, 110000
ChinaActive - Recruiting
Tianjin Medical University General Hospital
Tianjin, 30052
ChinaActive - Recruiting
Affiliated Hospital, Xuzhou Medical college
Xuzhou, 221009
ChinaActive - Recruiting
Thomayer University Hospital
Prague, 140 59
CzechiaActive - Recruiting
Odense University Hospital
Odense, 5000
DenmarkActive - Recruiting
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki, 00029
FinlandActive - Recruiting
Oulun yliopistollinen keskussairaala
Oulu, 90220
FinlandActive - Recruiting
TYKS
Turku, 20520
FinlandActive - Recruiting
HOP d'Angers
Angers, 49933
FranceActive - Recruiting
HOP Avicenne
Bobigny, 93000
FranceSite Not Available
HOP CHU Caen
Caen, 14033
FranceActive - Recruiting
HOP Côte de Nacre
Caen, 14033
FranceActive - Recruiting
HOP Michallon
La Tronche, 38700
FranceActive - Recruiting
INS Coeur Poumon
Lille, 59037
FranceSite Not Available
HOP Nord
Marseille, 13915
FranceSite Not Available
HOP Nord-Marseille-61673
Marseille, 13915
FranceSite Not Available
HOP Nord Laennec
Nantes, 44093
FranceActive - Recruiting
HOP Bichat
Paris, 75877
FranceSite Not Available
HOP Haut-Lévêque
Pessac, 33604
FranceSite Not Available
HOP Charles Nicolle
Rouen, 76031
FranceSite Not Available
HOP Bretonneau
Tours, 37000
FranceActive - Recruiting
Universitätsklinikum Aachen, AöR
Aachen, 52074
GermanyActive - Recruiting
CIMS Studienzentrum Bamberg GmbH
Bamberg, 96049
GermanyActive - Recruiting
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 12351
GermanySite Not Available
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239
GermanyActive - Recruiting
Universitätsklinikum Freiburg
Freiburg, 79106
GermanyActive - Recruiting
Universitätsklinikum Hamburg, Eppendorf
Hamburg, 20246
GermanySite Not Available
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
GermanySite Not Available
Medizinische Hochschule Hannover
Hannover, 30625
GermanyActive - Recruiting
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126
GermanyActive - Recruiting
Krankenhaus Bethanien gGmbH
Solingen, 42699
GermanyActive - Recruiting
Helios Hanseklinikum Stralsund
Stralsund, 18435
GermanySite Not Available
Robert Bosch Gesellschaft für medizinische Forschung mbH
Stuttgart, 70376
GermanySite Not Available
Klinikum Würzburg Mitte gGmbH
Würzburg, 97074
GermanySite Not Available
Univ. Gen. Hosp. of Ioannina
Ioannina, 45 500
GreeceSite Not Available
Univ. Gen. Hosp. of Patras
Patras, 26504
GreeceActive - Recruiting
Hospital of Heraklion (PAGNI)
Voutes, 71500
GreeceActive - Recruiting
Koranyi National Institute For Pulmonolgy
Budapest, 1121
HungarySite Not Available
A. O. Universitaria Careggi
Firenze, 50137
ItalySite Not Available
Ospedale Colonnello D Avanzo
Foggia, 71100
ItalySite Not Available
Ospedale G.B. Morgagni
Forli', 47121
ItalySite Not Available
Ospedale G.B. Morgagni - L. Pierantoni AUSL Forlì
Forli', 47121
ItalySite Not Available
Azienda Ospedaliera San Martino
Genova, 16132
ItalySite Not Available
Osp. S. Giuseppe Fatebenefratelli
Milano, 20123
ItalyActive - Recruiting
Ospedale Classificato San Giuseppe
Milano, 20123
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria di Padova
Padova, 35128
ItalyActive - Recruiting
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Roma, 00189
ItalySite Not Available
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
ItalyActive - Recruiting
Pol. Universitario Tor Vergata
Roma, 00133
ItalyActive - Recruiting
Poli Univ A. Gemelli
Roma, 00168
ItalySite Not Available
Tosei General Hospital
Aichi, Seto, 489-8642
JapanSite Not Available
Chiba University Hospital
Chiba, Chiba, 260-8677
JapanSite Not Available
University of Fukui Hospital
Fukui, Yoshida-gun, 910-1193
JapanActive - Recruiting
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
JapanActive - Recruiting
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, 810-8563
JapanActive - Recruiting
Sapporo Medical University Hospital
Hokkaido, Sapporo, 060-8543
JapanActive - Recruiting
National Hospital Organization Himeji Medical Center
Hyogo, Himeji, 670-8520
JapanActive - Recruiting
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, 236-0051
JapanActive - Recruiting
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501
JapanSite Not Available
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, 591-8555
JapanSite Not Available
Hamamatsu University Hospital
Shizuoka, Hamamatsu, 431-3192
JapanSite Not Available
Tokushima University Hospital
Tokushima, Tokushima, 770-8503
JapanActive - Recruiting
Kyorin University Hospital
Tokyo, Mitaka, 181-8611
JapanSite Not Available
Toho University Omori Medical Center
Tokyo, Ota-ku, 143-8541
JapanActive - Recruiting
Center Hospital of the National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, 162-8655
JapanActive - Recruiting
National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, 162-8655
JapanActive - Recruiting
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon, 14647
Korea, Republic ofSite Not Available
Inje University Haeundae Paik Hospital
Busan, 48108
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam, 13620
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Inje University Sanggye Paik Hospital
Seoul, 01757
Korea, Republic ofCompleted
Kyung Hee University Hospital
Seoul, 02447
Korea, Republic ofSite Not Available
Severance Hospital
Seoul, 03722
Korea, Republic ofSite Not Available
Soonchunhyang University Hospital Seoul
Seoul, 04401
Korea, Republic ofSite Not Available
Hospital Sultan Idris Shah Serdang
Kajang, 43000
MalaysiaActive - Recruiting
Institut Perubatan Respiratori
Kuala Lumpur, 53000
MalaysiaActive - Recruiting
Sarawak General Hospital
Kuching, Sarawak, 93586
MalaysiaSite Not Available
Amphia Ziekenhuis
Breda, 4818 CK
NetherlandsSite Not Available
Erasmus Medisch Centrum-ROTTERDAM-50697
Rotterdam, 3015 GD
NetherlandsSite Not Available
Christchurch Hospital
Christchurch, 8011
New ZealandActive - Recruiting
Waikato Hospital
Hamilton, 3240
New ZealandActive - Recruiting
Greenlane Clinical Centre
One Tree Hill, Auckland, 1051
New ZealandActive - Recruiting
Haukeland Universitetssykehus
Bergen, N-5021
NorwayActive - Recruiting
Akershus Universitetssykehus HF
Lørenskog, 1478
NorwaySite Not Available
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, N-0372
NorwayActive - Recruiting
University Clinical Hospital in Bialystok I
Bialystok, 15-540
PolandSite Not Available
Alergopneuma Medical Center
Swidnik, 21040
PolandSite Not Available
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
Warsaw, 01-138
PolandSite Not Available
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
Warszawa, 01-138
PolandSite Not Available
Singapore General Hospital
Singapore, 169608
SingaporeActive - Recruiting
Tan Tock Seng Hospital
Singapore, 308433
SingaporeSite Not Available
Hospital General Universitario de Alicante
Alicante, 03010
SpainSite Not Available
Hospital Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital de Galdakao
Galdakao, 48960
SpainActive - Recruiting
Hospital de Bellvitge
L'Hospitalet de Llobregat, 08907
SpainSite Not Available
Hospital Universitario Infanta Leonor
Madrid, 28031
SpainSite Not Available
Hospital Virgen de la Victoria
Malaga, 29010
SpainActive - Recruiting
Hospital Central de Asturias
Oviedo, 33011
SpainActive - Recruiting
Hospital Quirónsalud Madrid
Pozuelo de Alarcón, 28223
SpainActive - Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, 39008
SpainSite Not Available
Hospital Clínico de Santiago
Santiago de Compostela, 15706
SpainSite Not Available
Hospital Virgen del Rocío
Sevilla, 41013
SpainSite Not Available
Skånes universitetssjukhus, Lund
Lund, 221 85
SwedenActive - Recruiting
CTC Clinical Trial Consultants AB
Uppsala, 752 37
SwedenActive - Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, 83301
TaiwanSite Not Available
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, 807
TaiwanActive - Recruiting
Taichung Veterans General Hospital
Taichung, 40705
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei, 10002
TaiwanSite Not Available
Chang Gung Memorial Hospital(Linkou)
TaoYuan, 333
TaiwanSite Not Available
Chulalongkorn Hospital
Bangkok, 10330
ThailandActive - Recruiting
Srinagarind Hospital
Khon Kaen, 40002
ThailandActive - Recruiting
Ramathibodi Hospital
Ratchatewi, 10400
ThailandActive - Recruiting
Songklanagarind Hospital
Songkhla, 90110
ThailandActive - Recruiting
Castle Hill Hospital
Cottingham, HU16 5JQ
United KingdomSite Not Available
Royal Devon and Exeter Hospital, Wonford
Exeter, EX2 5DW
United KingdomActive - Recruiting
Royal Lancaster Infirmary
Lancaster, LA1 4RP
United KingdomActive - Recruiting
Royal Brompton Hospital
London, SW3 6NP
United KingdomActive - Recruiting
Wythenshawe Hospital
Manchester, M23 9LT
United KingdomActive - Recruiting
Southampton General Hospital
Southampton, SO16 6YD
United KingdomActive - Recruiting
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesActive - Recruiting
The Medical Research Group
Fresno, California 93720
United StatesSite Not Available
A & A Research Consultants, LLC
Lakewood, Colorado 78539
United StatesSite Not Available
Critical Care, Pulmonary and Sleep Associates
Lakewood, Colorado 80228
United StatesSite Not Available
St. Francis Medical Institute
Clearwater, Florida 33765
United StatesSite Not Available
University of Florida Health Shands Hospital
Gainesville, Florida 32608
United StatesSite Not Available
Clinical Research Specialists LLC
Kissimmee, Florida 34746
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
The Iowa Clinic, PC
West Des Moines, Iowa 50266
United StatesActive - Recruiting
Infinity Medical Research
North Dartmouth, Massachusetts 02747
United StatesSite Not Available
Advanced Pulmonary Research
Warren, Michigan 48088
United StatesSite Not Available
Advanced Pulmonary Research Institute of Michigan
Warren, Michigan 48088
United StatesSite Not Available
Memorial Hospital Gulfport
Gulfport, Mississippi 39501
United StatesActive - Recruiting
Renown Regional Medical Center
Reno, Nevada 89502
United StatesSite Not Available
Northern Westchester Hospital
Mount Kisco, New York 10549
United StatesSite Not Available
Columbia University
New York, New York 10032
United StatesSite Not Available
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York 10032
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Mount Sinai Hospital-New York-52529
New York, New York 10029
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
New Bern, North Carolina 28562
United StatesActive - Recruiting
Southeastern Research Center
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Southeastern Research Center, LLC
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Southeastern Research Center-Winston Salem-69289
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
University of Oklahoma-Oklahoma City-59108
Oklahoma City, Oklahoma 73019
United StatesSite Not Available
Clinical Research Associates of Central PA
DuBois, Pennsylvania 15801
United StatesActive - Recruiting
Temple University
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
Temple University Hospital
Philadelphia, Pennsylvania 19140
United StatesActive - Recruiting
Infinity Medical Research, Inc.
East Providence, Rhode Island 02914
United StatesSite Not Available
Lowcountry Lung and Critical Care
Charleston, South Carolina 29406
United StatesActive - Recruiting
Spartanburg Medical Research
Spartanburg, South Carolina 29303
United StatesSite Not Available
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
A & A Research Consultants, LLC
Edinburg, Texas 78539
United StatesSite Not Available
Pulmonary and Sleep Center of the Valley
McAllen, Texas 78504
United StatesSite Not Available
University of Utah Health Sciences Center
Salt Lake City, Utah 84132
United StatesSite Not Available
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia 23230
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.